Multimodal Analgesia Versus Routine Care Pain Management (MMA)
Primary Purpose
Degenerative Disc Disease Lumbar, Spinal Stenosis, Lumbar Spondylolisthesis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multimodal Analgesia
Patient controlled analgesia
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease Lumbar focused on measuring Multi-modal Pain Management, Lumbar fusion, misTLIF
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing single level MIS-TLIF
- Patients able to provide informed consent
Exclusion Criteria:
- Allergies or other contraindications to medicines in the protocol
- Current liver disease with documented liver function test abnormality
- Current renal disese with documented glomerular filtration rate (GFR) < 60 mL/min/1.73m2
- Baseline (pre-operative) opioid use greater than 30 mg of morphine equivalents/day
- Active alcohol dependence
- Active illicit drug dependence
Sites / Locations
- Rush University Medical Center-Orthopedic Spine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multimodal analgesia
Patient Controlled analgesia
Arm Description
multiple analgesic medications utilized in a synergistic manner to control pain while minimizing side-effects of individual drugs due to decreased doses. This includes pre-operative patient education, intra-operative pain management and post-operative pain protocols.
Pain management using patient controlled narcotic analgesia.
Outcomes
Primary Outcome Measures
Numeric pain scale
(a) While in the hospital, patients' pain is assessed by a nurse-driven protocol. Assessments are every four to six hours, within 60 minutes after receiving an intravenous pain medication and within 90 minutes of receiving an oral pain medication. This assessment includes rating subjective rating of ones pain on a verbal numeric rating scale (NRS) of 0-10. The maximum pain score for each post-operative day will be compared.
Secondary Outcome Measures
Patient satisfaction
At each pain assessment (minimum every 4 hours), partients are asked if they are satisfied with their pain management. (yes/no)
Full Information
NCT ID
NCT01861743
First Posted
May 8, 2013
Last Updated
August 27, 2018
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01861743
Brief Title
Multimodal Analgesia Versus Routine Care Pain Management
Acronym
MMA
Official Title
Multimodal Analgesia Versus Routine Care Pain Management for Minimally Invasive Spine Surgery: A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
data was not collected accurately
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Most patients undergoing surgery experience significant post-operative pain. Inadequate peri-operative pain management may decrease post-operative mobilization and increase length of hospitalization. Additionally, poorly managed acute post-operative pain analgesia is associated with an increased risk of developing chronic pain and delayed wound healing.
Lumbar spine surgery is particularly painful, often requiring a multi-day hospitalization. The most common post-operative analgesia used in spine surgery is narcotic medication delivered via an intravenous patient controlled analgesia (IV PCA).
A multimodal peri-operative pain management protocol for spine surgery has the potential to not only decrease pain but also to improve recovery, decrease narcotic consumption, decrease length of stay in the hospital and reduce both direct and indirect hospital costs.
The purpose of this study is to determine if post-operative pain and rate of recovery are improved in patients undergoing spine surgery using MMA compared to usual analgesic care.
Detailed Description
We hypothesize patients undergoing spinal fusion who receive peri-operative MMA will have:
decreased post-operative pain compared to patients receiving usual care for pain management.
shorter hospital LOS compared to patients receiving usual care pain management.
fewer analgesic-related post-operative complications (urinary retention, ileus, etc) compared to patients receiving usual care pain management.
improved physical functioning at the time of hospital discharge compared to patients receiving usual care pain management.
better short and long term outcomes. Subjects will be randomized to MMA (Group 1) or usual care (Group 2). The unit of randomization will be a week (Monday through Sunday). Each week will randomly be assigned to MMA or usual care. Subjects who are hospitalized into a consecutive week will continue with the pain regimen they were assigned upon hospitalization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease Lumbar, Spinal Stenosis, Lumbar Spondylolisthesis
Keywords
Multi-modal Pain Management, Lumbar fusion, misTLIF
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multimodal analgesia
Arm Type
Experimental
Arm Description
multiple analgesic medications utilized in a synergistic manner to control pain while minimizing side-effects of individual drugs due to decreased doses. This includes pre-operative patient education, intra-operative pain management and post-operative pain protocols.
Arm Title
Patient Controlled analgesia
Arm Type
Active Comparator
Arm Description
Pain management using patient controlled narcotic analgesia.
Intervention Type
Other
Intervention Name(s)
Multimodal Analgesia
Intervention Description
Subjects are given medications preop, intraop and postop that implement a multi-modal approach to managing pain.
Intervention Type
Other
Intervention Name(s)
Patient controlled analgesia
Intervention Description
Subjects will be treated with patient controlled narcotic analgesia for pain management.
Primary Outcome Measure Information:
Title
Numeric pain scale
Description
(a) While in the hospital, patients' pain is assessed by a nurse-driven protocol. Assessments are every four to six hours, within 60 minutes after receiving an intravenous pain medication and within 90 minutes of receiving an oral pain medication. This assessment includes rating subjective rating of ones pain on a verbal numeric rating scale (NRS) of 0-10. The maximum pain score for each post-operative day will be compared.
Time Frame
Patients will be followed post-operatively while in the hospital (Avg 1-3 days), and a 6 weeks, 3 months, 6 months, 1 year and 2 years.
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
At each pain assessment (minimum every 4 hours), partients are asked if they are satisfied with their pain management. (yes/no)
Time Frame
Post operatively (avg: 1-3 days)
Other Pre-specified Outcome Measures:
Title
Length of Stay
Time Frame
Post operatively (avg: 1-3 days)
Title
Discharge destination
Description
Determine whether patients are discharged to home or to another facility (e.g. rehab, etc)
Time Frame
Post operatively (avg:1-3 days)
Title
Adverse events
Time Frame
Post operatively (avg: 1-3 days)
Title
Disease specific and General health outcome measures
Description
Short form 36 and the Oswestry Disabilty Index
Time Frame
Pre operatively (within 1 month of date of surgery) and Post operatively (6 weeks, 3months, 6 months, 1 year and 2 years)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients undergoing single level MIS-TLIF
Patients able to provide informed consent
Exclusion Criteria:
Allergies or other contraindications to medicines in the protocol
Current liver disease with documented liver function test abnormality
Current renal disese with documented glomerular filtration rate (GFR) < 60 mL/min/1.73m2
Baseline (pre-operative) opioid use greater than 30 mg of morphine equivalents/day
Active alcohol dependence
Active illicit drug dependence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank M Phillips, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center-Orthopedic Spine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21372654
Citation
Kim JC, Choi YS, Kim KN, Shim JK, Lee JY, Kwak YL. Effective dose of peri-operative oral pregabalin as an adjunct to multimodal analgesic regimen in lumbar spinal fusion surgery. Spine (Phila Pa 1976). 2011 Mar 15;36(6):428-33. doi: 10.1097/BRS.0b013e3181d26708.
Results Reference
result
PubMed Identifier
20375829
Citation
Rajpal S, Gordon DB, Pellino TA, Strayer AL, Brost D, Trost GR, Zdeblick TA, Resnick DK. Comparison of perioperative oral multimodal analgesia versus IV PCA for spine surgery. J Spinal Disord Tech. 2010 Apr;23(2):139-45. doi: 10.1097/BSD.0b013e3181cf07ee.
Results Reference
result
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Multimodal Analgesia Versus Routine Care Pain Management
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